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Review
. 2025 Aug 29;20(1):73.
doi: 10.5334/gh.1457. eCollection 2025.

WHF Roadmap on Single Pill Combination Therapies

Enrico G Ferro  1   2 , Gautam Satheesh  3   4   5 , José Castellano  6 , Albertino Damasceno  7 , Okeoma Erojikwe  8 , Mark Huffman  9 , Vilma Irazola  10 , Philip Joseph  11 , Fernando Lanas  12 , Elijah Ogola  13 , Pedro Ordunez  14 , Pablo Perel  15   16 , Daniel Pineiro  17 , Izabela Uchmanowicz  18 , Orly Vardeny  19 , Ruth Webster  20 , Habib Gamra  21 , Thomas Gaziano  22 , Adrianna Murphy  23
Affiliations
Review

WHF Roadmap on Single Pill Combination Therapies

Enrico G Ferro et al. Glob Heart. .

Abstract

Cardiovascular diseases (CVDs) are the leading global cause of mortality, with treatment adherence posing a major barrier to effective prevention and control. Single pill combinations (SPCs), also known as fixed-dose combinations, simplify treatment by combining multiple agents into one pill, improving adherence and reducing cardiovascular risk. This World Heart Federation Roadmap synthesizes the latest clinical evidence and identifies key barriers to SPC implementation, including limited manufacturing, affordability, regulatory complexity, and inconsistent guideline inclusion. Drawing on global expert input and health systems analysis, the Roadmap outlines practical, context-specific solutions to improve access, scale-up, and integration of SPCs into national strategies, especially in low- and middle-income countries. It serves as a tool for policymakers, clinicians, and advocates to drive progress in aligning cardiovascular prevention efforts with evidence-based, people-centred care.

Keywords: Cardiovascular disease; polypill; prevention; single pill combinations.

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Conflict of interest statement

AD has received speaker honoraria from Astra Zeneca, Sanofi and Bayer and has participated in a research project supported by Bayer. DJP has received honorary speakers from Ferrer, Lepetit, Siemens, and TEVA. Institute of PJ has received funding for polypill related research. MDH has received travel support from the American Heart Association and World Heart Federation. MDH has an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH has pending patents for heart failure polypills.

Figures

Timeline plotting SPC historical milestones from 2001 to 2023
Figure 1
Development and Implementation of Single Pill Combinations for Cardiovascular Disease. Figure Legend. Milestones in the history of SPC for cardiovascular disease are listed chronologically and separated into two categories: scientific evidence to support the use of SPC in primary and secondary CVD prevention (bottom), and key events towards real-world adoption of SPC (top). The colour coding of the boxes is used to represent the progression in each of the two domains: from trials limited to intermediate outcomes (red) to trials evaluating clinical outcomes (yellow) to systematic meta-analyses (green) for the scientific evidence domain; and from SPC idea conceptualization (red) to manufacturing efforts (yellow) to policy implementation (green) for the real-world adoption domain. Acronyms: Blood pressure (BP); cardiovascular disease (CVD); essential medicine list (EML); single pill combination (SPC); high-income countries (HIC); low- and middle-income countries (LMIC); low-density lipoprotein (LDL); major adverse cardiovascular events (MACE); randomized controlled trial (RCT); standard of care (SOC).
See this image and copyright information in PMC

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